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临床试验/NCT02647957
NCT02647957已完成不适用

Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain

Universidad Miguel Hernandez de Elche0 个研究点目标入组 240 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
主要终点
Recovery rate of the Intravenous trombolysis treatment

研究概览

简要总结

Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).

详细描述

In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent.

A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •acute ischemic stroke in-patients

排除标准

  • •Patients who refuse participate

研究组 & 干预措施

Group A

Experimental

Hospital using Code Stroke

干预措施: Code Stroke (Procedure)

Group B

No Intervention

Hospital not using Code Stroke

结局指标

主要结局

Recovery rate of the Intravenous trombolysis treatment

时间窗: 1 month

Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.

次要结局

  • Patient satisfaction(1 month)
  • Mortality rates of the Intravenous trombolysis treatment(1 month)
  • Treatment adequacy: Intravenous trombolysis treatment(1 month)
  • Patient engage(1 month)
  • response capacity(1 day)
  • Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Joaquín Mira

Professor

Universidad Miguel Hernandez de Elche

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